Abstract

Background

Extracorporeal Membrane Oxygenation (ECMO) is a technology used in treatment of patients
with severe but potentially reversible respiratory failure. A multi-centre randomised
controlled trial (CESAR) was funded in the UK to compare care including ECMO with
conventional intensive care management. The protocol and funding for the CESAR trial
included plans for economic data collection and analysis. Given the high cost of treatment,
ECMO is considered an expensive technology for many funding systems. However, conventional
treatment for severe respiratory failure is also one of the more costly forms of care
in any health system.

Methods/Design

The objectives of the economic evaluation are to compare the costs of a policy of
referral for ECMO with those of conventional treatment; to assess cost-effectiveness
and the cost-utility at 6 months follow-up; and to assess the cost-utility over a
predicted lifetime. Resources used by patients in the trial are identified. Resource
use data are collected from clinical report forms and through follow up interviews
with patients. Unit costs of hospital intensive care resources are based on parallel
research on cost functions in UK NHS intensive care units. Other unit costs are based
on published NHS tariffs. Cost effectiveness analysis uses the outcome: survival without
severe disability. Cost utility analysis is based on quality adjusted life years gained
based on the Euroqol EQ-5D at 6 months. Sensitivity analysis is planned to vary assumptions
about transport costs and method of costing intensive care. Uncertainty will also
be expressed in analysis of individual patient data. Probabilities of cost effectiveness
given different funding thresholds will be estimated.

Discussion

In our view it is important to record our methods in detail and present them before
publication of the results of the trial so that a record of detail not normally found
in the final trial reports can be made available in the public domain.